The urogenital area is a sensitive region with a delicate balance of moisture, fat and microorganisms, which is easily disturbed and which may cause discomfort and smarting. For example, the balance may be disturbed by extensive cleaning, the use of antibiotics or antifungal agents, and the use of absorbent articles that may dry out the skin and mucous membranes. It is known that the administration of different substances to the urogenital area, such as prebiotics, probiotics, skin soothing substances etc., may improve the balance in the urogenital area and/or prevent discomfort.
The urogenital area harbors a complex microbial ecosystem comprising more than 50 different bacterial species (Hill et al., Scand. J. Urol. Nephrol. 1984; 86 (suppl.) 23-29). The microbial ecosystem of a healthy individual can be disturbed by the use of antibiotics, during hormonal changes, such as during pregnancy or use of contraceptives with estrogen, during menstruation, after menopause, in people suffering from diabetes etc. Also, microorganisms may spread from the anus to the urogenital area, thereby causing infections. This results in a disturbance of the normal microbial flora and leaves the individual susceptible to microbial infections that cause vaginitis, urinary tract infections and ordinary skin infections. The dominating species in this area for fertile women are lactic acid producing bacteria. Examples of such bacteria include bacteria belonging to the genus Lactobacillus, Lactococcus, Bacillus and Bifidobacteria. These lactic acid producing members are important for retaining a healthy microbial flora in these areas, and act as probiotic bacteria with an antagonistic effect against pathogenic microbial species. Lactic acid producing bacteria inhibit growth and colonization by other microorganisms by occupying suitable niches for colonization, by forming biofilms and competing for available nutrients, thereby excluding colonization by harmful microorganisms. Also, the production of hydrogen peroxide, specific inhibiting substances, such as bacteriocines, and organic acids (including lactic acid and acetic acid) that lower the pH, inhibit colonization by other microorganisms.
Similarly to the urogenital area, the skin has a delicate balance of moisture, fat and microorganisms, which is easily disturbed by conditions that dry out the skin and that disturb the microbial balance, such as extensive cleaning.
Traditionally infections in the urogenital area and the skin caused by undesirable microbial organisms have been treated by the administration of antibacterial and antifungal agents to the affected body part. Although such agents may be used to treat infections, they may also in themselves cause a disturbed microflora.
More recently, the administration of probiotic bacteria, such as lactic acid producing bacteria, to the urogenital area and the skin has been suggested to be used in order to outcompete pathogenic species and facilitate reestablishment and maintenance of a beneficial microbial flora in these areas.
Other additives that may be used in order to improve the urogenital and skin milieu, and that therefore may be interesting to deliver to these areas, include prebiotics. Prebiotics promote a balanced microflora when administered in adequate amounts to a host. Examples are nutrition for probiotic bacteria, substances that promote adhesion to the host of probiotic bacteria and pH-regulating substances.
In addition, it may be of interest to deliver additives, such as pH regulating substances, to the skin and/or urogenital area in order to maintain and/or achieve a low pH which may be desirable. Other examples of substances that may be used to improve the milieu of skin and/or urogenital area include humidity stabilization substances, hydrophobic substances, antioxidants, skin soothing substances and odor inhibiting substances.
Additives such as cooling substances, anti-itching substances and aromatic substances may also be delivered to the skin and/or urogenital area for increased comfort.
One way to deliver these additives to the skin and/or urogenital area is to provide them via sanitary articles, such as hygiene tissues and absorbent articles. For example, it has been suggested that probiotic bacteria can be delivered via absorbent products, such as diapers, sanitary napkin, incontinence guards, panty liners and tampons, as described in, for example, WO 92/13577, WO 97/02846, WO 99/17813, WO 99/45099 and WO 00/35502. It has also been suggested to deliver probiotic bacteria via hygiene tissues, as disclosed in WO 04/060416.
However, when additives are to be delivered via sanitary articles, it is often desirable and/or necessary to enclose the additives before use of the sanitary article for different reasons.
Probiotics and odor inhibiting substances are often moisture sensitive and lose their effect when exposed to moisture. Therefore, it may be necessary to enclose such additives in moisture impervious packages during transport and storage of hygiene products comprising them.
It may also be necessary to protect the additives to be delivered from oxidation. For example, fatty acids may oxidize when in contact with air and become rancid. Other additives, such as aromatic substances and perfume, may need to be protected from evaporation. U.S. Pat. No. 2,066,946, e.g., discloses a sanitary napkin with a sealed envelope comprising an active chemical, wherein the envelope is used to keep the active chemical out of contact with the materials of the sanitary napkin and out of contact with air and vapor during storage.
It may also be desirable to have the additive to be delivered via a sanitary article in a confined area of the product in order to not spread to other parts of the product before and/or during use. When folding and packaging a sanitary article, a sticky additive, such as an additive comprising a hydrophobic substance, may stick to the package or smear over the product in an undesired manner which makes the product look messy or which may impair its function, e.g., by reducing its liquid absorbing properties. In particular, fatty acids and other hydrophobic additives may impair the liquid absorbent properties of absorbent products and therefore need to be protected from being spread over the product during transport and storage. Also, it may be of interest to deliver the additive to a specific body area of a user of the sanitary article. It may thus be preferable to have means for placing and keeping the additive in a position on the sanitary article so that this can be achieved. In addition, as the additives are to be delivered to the skin and/or urogenital area, which are sensitive areas, the means for delivery has to be comfortable to use and not causing discomfort.
Consequently, there is still a need to develop improved ways of delivering additives to the skin and/or urogenital area which protect additives from the surrounding milieu and/or keep them in a confined space, so that it is ensured that these additives are not destroyed during transport and storage and that also ensures that the properties of the sanitary article they are to be delivered via are retained. It is also of uttermost importance that the products are user friendly and comfortable to use. Also, it is desirable to provide a sanitary article wherein the delivery device is an integrated part of the sanitary article. Therefore, it is also of interest that the delivery device has means for attaching it to a sanitary article. In addition, there is still a need to develop manufacturing processes that are more efficient and less expensive.